- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02089672
RF Lesion Monitoring With 8mm IntellaTip MiFi XP
Radiofrequency Ablation Lesion Monitoring Using Imbedded Micro-Electrodes Versus Standard Bipolar Electrograms
Abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter is introduced into the heart. These catheters can then cauterize abnormally functioning portions of the heart muscle with the hope of returning the heart to a more effective rhythm. In the process of performing such a procedure, called a catheter ablation, an operator must be able to accurately sense electrical activity displayed on computer screens in different parts of the heart, provide sufficient localized energy to the abnormally behaving tissue (ideally without damaging uninvolved heart structures), and accurately reassess the electrical activity of the heart to ensure the spot in the heart has been cauterized.
When sensing electrical activity of the heart, specialized catheters produce recordings on a computer screen known as electrograms (EGM). To produce this recording conventional catheters commonly use a positive and negative electrode, from which the difference between the two provides the EGM. The distance between the two electrodes varies from device to device. The greater the distance between them, the less accurate the measurement of local electrical activity becomes. This may result in poorly localized or excessive use of energy that could be damaging to normal heart structures or put the patient at risk for the return or development of additional arrhythmias. The IntellaTip MiFi catheter has been constructed with a specialized sensing tip that uses "microelectrodes" that are relatively close in proximity (<1 mm apart) with the hope of improving the sensing capability of the device.
This study will analyze the signals obtained from this FDA-approved catheter in people undergoing a catheter ablation procedure. The study will examine signals after the procedure is finished and will not prolong or differ the process from a standard ablation procedure. The goal of this study is to determine the ability of the microelectrodes to distinguish ablated, or cauterized versus non-cauterized tissue.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Emory University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Any adult undergoing an atrial flutter ablation
Exclusion Criteria:
-
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Atrial flutter patients
Atrial flutter patients undergoing catheter ablation
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This is observational trial studying the effects of a standard intervention of a catheter ablation procedure.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Total bipolar electrogram amplitude using tip to ring and pin to pin configurations
Délai: Acute, averaged one hour during ablation. Measured postoperatively.
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Acute, averaged one hour during ablation. Measured postoperatively.
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Total number of seconds per isthmus ablation spent in excess of the post-hoc identified complete lesion time.
Délai: Acute, averaged one hour during ablation. Measured postoperatively
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Acute, averaged one hour during ablation. Measured postoperatively
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Michael Lloyd, MD FHRS FACC, Emory University
Publications et liens utiles
Publications générales
- Hogh Petersen H, Chen X, Pietersen A, Svendsen JH, Haunso S. Lesion dimensions during temperature-controlled radiofrequency catheter ablation of left ventricular porcine myocardium: impact of ablation site, electrode size, and convective cooling. Circulation. 1999 Jan 19;99(2):319-25. doi: 10.1161/01.cir.99.2.319.
- Sanchez JE, Kay GN, Benser ME, Hall JA, Walcott GP, Smith WM, Ideker RE. Identification of transmural necrosis along a linear catheter ablation lesion during atrial fibrillation and sinus rhythm. J Interv Card Electrophysiol. 2003 Feb;8(1):9-17. doi: 10.1023/a:1022315308803.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00069674
- ISRCRM90003 (Autre identifiant: Other)
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